Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes

This study will investigate whether low-calorie sweeteners (LCS) are helpful or harmful for preventing diabetes complications among children with Type 1 Diabetes (T1D).

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Low-calorie sweetener restriction

Detailed Description

Eligible participants will be scheduled for a baseline visit. During the week prior, they will be instructed to continue usual dietary habits and complete an online photo-assisted food record, with parental assistance. At the baseline visit, height and weight will be measured, a spot urine sample will be collected, and a blood draw will be performed. Participants will have their CGM data for the past two weeks downloaded. In a subset of participants, an abdominal MRI will also be performed.

Subjects will then be randomized to either: 1) low-calorie sweetener (LCS) restriction or 2) continuation of usual LCS intake (control). All participants (both groups) and their parent will undergo a brief, 20-minute orientation where the PI and study dietitian will provide an introduction to the study, instructions on completing food records, education on CGM. Those in the intervention group will be given sample replacement beverages and a brochure on avoiding LCS to take home which will include a list of specific foods and beverages containing LCS to avoid during the study. Participants in the control group will be counseled on healthy eating as those in the intervention group (in accordance with standard dietary guidance for T1D management), with the exception of information and resources for avoiding LCS.

In both groups, text messages will be sent to parents 3X/week with reminders that their child should avoid LCS or continue usual intake, per randomization. Adherence will be monitored through collection of spot-urine samples for measurement of sucralose and ace-K concentrations. daily text message beverage logs completed by the parent, and photo-assisted food records with parent assistance in Weeks 0, 1, 6, and 12. During Week 6, participants and their parent will attend a mid-intervention telemedicine booster visit, during which the PI and/or study RA will reinforce the intervention and remind participants to mail back a spot urine sample using materials provided by the study team at baseline. Participants will be reminded of the study instructions, including the importance of inserting the DEXCOM G6 sensor (provided by study team) at the beginning of Week 11.

At the end of Week 12, participants and their parent will return for follow-up. Participants will have their CGM data downloaded using DEXCOM Clarity™ software. Height and weight will be measured and a second blood draw performed. Those who had an MRI at the baseline visit (n=30) will undergo a second abdominal MRI. Those randomized to the intervention will be purposefully sampled and asked to complete a ~20 minute qualitative interview and ~5 minute satisfaction survey, together with their parent, about their study experience and the challenges of LCSB restriction.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison C Sylvetsky; Phone Number: 2029945602; Email: asylvets@gwu.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Child 6-12 years old
2. Report consumption of ≥ 12 oz. beverages with sucralose (+/- ace-K) or aspartame+ace-K per day
3. Child has had a diagnosis of T1D for at least one year
4. Parent/guardian has reliable phone and internet access
5. Parent/guardian and child both speak English
6. Child is enrolled in the Diabetes Program at Children's National Hospital

Exclusion Criteria:

1. Child under 6 years of age
2. Child older than 12 years of age
3. Child consumes foods with low-calorie sweeteners more than 3 times per week
4. Child consumes condiments with low-calorie sweeteners more than 3 times per week
5. Child has poorly managed chronic disease other than T1D or is taking medications other than insulin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-calorie sweetener restriction; Participants will be instructed to avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks.	Behavioral: Low-calorie sweetener restriction; Participants will avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners for 12 weeks and will instead consume unsweetened alternatives, such as still or sparkling water
No Intervention: Usual consumption/control; Participants will continue low-calorie sweetener consumption, as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Variability	Change in Time in Range (TIR)	Baseline vs Weeks 11-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visceral adiposity	Visceral fat area will be assessed using abdominal MRI	Baseline vs. Week 12
Inflammatory cytokines (e.g. IL-6)	We will collect a blood sample to measure inflammatory cytokines.	Baseline vs Week 12

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: Children's National Research Institute

Publications and helpful links

General Publications

• Sylvetsky AC, Moore HR, Kaidbey JH, Halberg SE, Cogen FR, DiPietro L, Elmi A, Goran MI, Streisand R. Rationale and design of DRINK-T1D: A randomized clinical trial of effects of low-calorie sweetener restriction in children with type 1 diabetes. Contemp Clin Trials. 2021 Jul;106:106431. doi: 10.1016/j.cct.2021.106431. Epub 2021 May 8.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Pro00012436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No